Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Neoplasm Metastasis

Breast Diseases

Skin Diseases

The additional MRI will take place biennially after the regular screening mammogram for a study period of 6 years.

No further follow-up until next scheduled screening examination two years later (according to the current Dutch guideline).

Gadolinium contrast is administered as a bolus with a standard dose of 0.1 mL/kg followed by a saline flush of 30 mL.

Contrast enhanced breast MRI

Carla H van Gils, PhD

Wouter B Veldhuis, MD PhD

The purpose of this study is to determine the cost-effectiveness of biennial screening with mammography and MRI compared to mammography alone in women aged 50-75 years and who show \> 75% mammographic density.

Women with very high mammographic density have a four to six fold higher breast cancer risk than women with low mammographic density. At the same time, the sensitivity of mammography is seriously impaired in women with high mammographic density, leading to many missed cases. Nevertheless, in the Netherlands this high risk group is currently screened between the age of 50 and 75 years with mammography only. MRI is likely to lead to better detection of breast tumors in women with high mammographic density, because it has a much higher sensitivity than mammography. The DENSE trial investigates the additional value of MRI for breast cancer screening in this risk group. Participants with extremely dense breasts (ACR4) and a negative mammogram are randomized to 'additional MRI' (n=7,237) versus 'current practice' (n=28,948).

Breast Cancer Screening With MRI in Women Aged 50-75 Years With Extremely Dense Breast Tissue: the DENSE Trial

The intervention will be carried out for six years, i.e. 3 screening rounds. Given a two year recruitment period, the total study time will be 8 years.

The MRI examination will take place every two years (0, 2 and 4 years after inclusion). Given a two year recruitment period, the total study time will be 6 years.

Dutch Breast Cancer Screening Organisations

Dutch Reference Centre for Screening

National Institute for Public Health and the Environment (RIVM)

The Netherlands Cancer Institute

University Medical Center Nijmegen

Jeroen Bosch Ziekenhuis

Albert Schweitzer Hospital

Hospital Group Twente (ZGT)

Amsterdam UMC, location VUmc

Maastricht University Medical Center

ZonMw: The Netherlands Organisation for Health Research and Development

Dutch Cancer Society

Pink Ribbon Inc.

A Sister's Hope

Bayer

Stichting Kankerpreventie Midden-West

Volpara Solutions

UMC Utrecht

Professor of Clinical Epidemiology of Cancer

Spots Global Cancer Trial Database for contrast enhanced breast mri